Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire (NPSI)

NCT ID: NCT04470206

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-19

Study Completion Date

2023-12-19

Brief Summary

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Several studies have shown the efficacy of spinal cord stimulation in reducing the intensity of neuropathic pain. This efficacy is defined as obtaining relief of at least 50% of the preoperative pain intensity assessed by the visual analog scale or the digital pain scale. No study has evaluated the efficacy of stimulation specifically on the different components of neuropathic pain, only an overall improvement in pain has been described.

A specific questionnaire for neuropathic pain has been extensively validated in neuropathic pain: the Neuropathic Pain Symptom Inventory (NPSI).

Thanks to the multidimensional structure of this questionnaire, investigators propose to evaluate separately and in a much more specific way the efficacy of spinal cord stimulation in the short and long term on the different components of neuropathic pain and to define responders subgroups.

Detailed Description

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Conditions

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Neuropathic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* With neuropathic pain:

* confirmed (DN4 score\> 4/10)
* going back to one year at least
* refractory to well-conducted medical treatments
* Requiring spinal cord stimulation: the indication is validated by the multidisciplinary meeting (RCP Neuromodulation / Pain at Foch Hospital)
* Having given his non-opposition

Exclusion Criteria

* Patient with sepsis
* Having no well-conducted prior medical treatment
* With uncontrolled psychiatric disorders (active psychosis, suicidal disorders, severe depression)
* with somatoform disorders
* addicted to alcohol or drugs or withdrawal syndrome
* Deprived of liberty or under guardianship.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naoufel Ouerchefani, MD

Role: PRINCIPAL_INVESTIGATOR

Foch Hospital

Locations

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Hôpital Foch

Suresnes, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Naoufel Ouerchefani, MD

Role: CONTACT

01 46 25 35 33 ext. 0033

Facility Contacts

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Naoufel Ouerchefani, MD

Role: primary

0033 1 46 25 35 33

Other Identifiers

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2020_0080

Identifier Type: -

Identifier Source: org_study_id

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